Dein persönlicher KI-Karriere-Agent
Regulatory Affairs Specialist(m/w/x)
Coordinating regulatory submissions for medical devices at global healthcare technology firm. 2-5 years medical device regulatory experience with Swissmedic submissions and trilingual proficiency (DE, EN, FR) essential. International regulatory environment, advanced tracking systems.
Anforderungen
- Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
- 2-5 years of medical device regulatory experience tied to Swissmedic submissions and processes
- Proficiency in German, English, and French
- Experience in ISO 13485 Quality Management Systems and risk management (ISO 14971, EN 14971)
- Experience with Swissmedic registration processes and technical documentation preparation
Aufgaben
- Coordinate and prepare document packages for regulatory submissions
- Lead and compile materials for submissions, license renewals, and annual registrations
- Recommend changes for labeling, manufacturing, marketing, and clinical protocols
- Monitor and improve tracking and control systems
- Stay updated on regulatory procedures and changes
- Interact with regulatory agencies on defined matters
- Suggest strategies for timely approvals of clinical trial applications
- Recommend improvements to enhance system and process effectiveness
- Communicate regularly with internal stakeholders to share updates and gather input
- Guide entry-level professionals or support staff as needed
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
- Französisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Competitive salary
Sonstige Vorteile
- Flexible benefits package
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Regulatory Affairs Specialist(m/w/x)
Coordinating regulatory submissions for medical devices at global healthcare technology firm. 2-5 years medical device regulatory experience with Swissmedic submissions and trilingual proficiency (DE, EN, FR) essential. International regulatory environment, advanced tracking systems.
Anforderungen
- Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
- 2-5 years of medical device regulatory experience tied to Swissmedic submissions and processes
- Proficiency in German, English, and French
- Experience in ISO 13485 Quality Management Systems and risk management (ISO 14971, EN 14971)
- Experience with Swissmedic registration processes and technical documentation preparation
Aufgaben
- Coordinate and prepare document packages for regulatory submissions
- Lead and compile materials for submissions, license renewals, and annual registrations
- Recommend changes for labeling, manufacturing, marketing, and clinical protocols
- Monitor and improve tracking and control systems
- Stay updated on regulatory procedures and changes
- Interact with regulatory agencies on defined matters
- Suggest strategies for timely approvals of clinical trial applications
- Recommend improvements to enhance system and process effectiveness
- Communicate regularly with internal stakeholders to share updates and gather input
- Guide entry-level professionals or support staff as needed
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
- Französisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Competitive salary
Sonstige Vorteile
- Flexible benefits package
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Medtronic
Branche
Healthcare
Beschreibung
The company leads global healthcare technology and aims to alleviate pain, restore health, and extend life.
Noch nicht perfekt?
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